Hemodynamic Results and Mid-term Follow-up of 850 19 to 23 mm Perimount Magna Ease Valves

Abstract

Background Aortic valve replacement (AVR) in small aortic roots remains a surgical dilemma with a higher risk of patient-prosthesis mismatch (PPM). The Perimount Magna Ease aortic valve (PMEAV) represents an attractive device in such cases. We examined the early hemodynamic performance, the mid-term outcomes of the PMEAV, and the impact of PPM on outcome and functional class.

Methods We performed a retrospective analysis of prospectively collected in-hospital data, and a prospective single-center follow-up of 849 patients who received a 19 to 23 mm PMEAV (2008–2014). Concomitant mitral or tricuspid replacement was the exclusion criterion. Early hemodynamic features were prospectively collected; mid-term follow-up was conducted according to current guidelines.

Results Size of implanted prosthesis was 19 mm in 11.5% of patients, 21 mm in 36.9%, and 23 mm in 51.5%. Operative mortality was 4.5% (3.1% for isolated AVR). The rate of severe and moderate PPMs was significantly higher in the 19 mm group. Follow-up was 99.9% complete (3.7 ± 2 years). Actuarial freedom from structural valve deterioration (SVD) at 5 years was 99.1%. At stratified Kaplan–Meier's analysis, PPM and age <70 years were associated with SVD. PPM was not associated with worse functional status (New York Heart Association class) or mortality at follow-up.

Conclusion This series shows satisfactory clinical outcomes of the PMEAV implanted in small aortic annuli at mid-term follow-up. Although PPM may occur in smaller sizes, it has limited clinical impact, and it is not associated with mid-term mortality or worse functional class. Few SVD events are evidenced; nonetheless, limited follow-up duration and its methodology need to be considered.

Keywords

aortic valve replacement - patient-prosthesis mismatch - follow-up

• References

• 1 Pibarot P, Dumesnil JG. Prosthesis-patient mismatch: definition, clinical impact, and prevention. Heart 2006; 92 (08) 1022-1029
• 2 Head SJ, Mokhles MM, Osnabrugge RL. , et al. The impact of prosthesis-patient mismatch on long-term survival after aortic valve replacement: a systematic review and meta-analysis of 34 observational studies comprising 27 186 patients with 133 141 patient-years. Eur Heart J 2012; 33 (12) 1518-1529
• 3 Chen J, Lin Y, Kang B, Wang Z. Indexed effective orifice area is a significant predictor of higher mid- and long-term mortality rates following aortic valve replacement in patients with prosthesis-patient mismatch. Eur J Cardiothorac Surg 2014; 45 (02) 234-240
• 4 Mohty D, Dumesnil JG, Echahidi N. , et al. Impact of prosthesis-patient mismatch on long-term survival after aortic valve replacement: influence of age, obesity, and left ventricular dysfunction. J Am Coll Cardiol 2009; 53 (01) 39-47
• 5 Kulik A, Al-Saigh M, Chan V. , et al. Enlargement of the small aortic root during aortic valve replacement: is there a benefit?. Ann Thorac Surg 2008; 85 (01) 94-100
• 6 Cheng D, Pepper J, Martin J. , et al. Stentless versus stented bioprosthetic aortic valves: a systematic review and meta-analysis of controlled trials. Innovations (Phila) 2009; 4 (02) 61-73
• 7 Une D, Ruel M, David TE. Twenty-year durability of the aortic Hancock II bioprosthesis in young patients: is it durable enough?. Eur J Cardiothorac Surg 2014; 46 (05) 825-830
• 8 Totaro P, Degno N, Zaidi A, Youhana A, Argano V. Carpentier-Edwards PERIMOUNT Magna bioprosthesis: a stented valve with stentless performance?. J Thorac Cardiovasc Surg 2005; 130 (06) 1668-1674
• 9 Botzenhardt F, Eichinger WB, Bleiziffer S. , et al. Hemodynamic comparison of bioprostheses for complete supra-annular position in patients with small aortic annulus. J Am Coll Cardiol 2005; 45 (12) 2054-2060
• 10 Bourguignon T, Lhommet P, El Khoury R. , et al. Very long-term outcomes of the Carpentier-Edwards Perimount aortic valve in patients aged 50-65 years. Eur J Cardiothorac Surg 2016; 49 (05) 1462-1468
• 11 Johnston DR, Soltesz EG, Vakil N. , et al. Long-term durability of bioprosthetic aortic valves: implications from 12,569 implants. Ann Thorac Surg 2015; 99 (04) 1239-1247
• 12 Wendt D, Thielmann M, Plicht B. , et al. The new St Jude Trifecta versus Carpentier-Edwards Perimount Magna and Magna Ease aortic bioprosthesis: is there a hemodynamic superiority?. J Thorac Cardiovasc Surg 2014; 147 (05) 1553-1560
• 13 Fiegl K, Deutsch MA, Rondak IC, Lange R, Guenzinger R. Matched comparison of two different biological prostheses for complete supra-annular aortic valve replacement. Thorac Cardiovasc Surg 2015; 63 (06) 459-466
• 14 Wyss TR, Bigler M, Stalder M. , et al. Absence of prosthesis-patient mismatch with the new generation of Edwards stented aortic bioprosthesis. Interact Cardiovasc Thorac Surg 2010; 10 (06) 884-887 , discussion 887–888
• 15 Anselmi A, Flécher E, Ruggieri VG. , et al. Long-term results of the Medtronic Mosaic porcine bioprosthesis in the aortic position. J Thorac Cardiovasc Surg 2014; 147 (06) 1884-1891
• 16 Akins CW, Miller DC, Turina MI. , et al; Councils of the American Association for Thoracic Surgery; Society of Thoracic Surgeons; European Association for Cardio-Thoracic Surgery; Ad Hoc Liaison Committee for Standardizing Definitions of Prosthetic Heart Valve Morbidity. Guidelines for reporting mortality and morbidity after cardiac valve interventions. J Thorac Cardiovasc Surg 2008; 135 (04) 732-738
• 17 Kappetein AP, Head SJ, Généreux P. , et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. Eur Heart J 2012; 33 (19) 2403-2418
• 18 Blais C, Dumesnil JG, Baillot R, Simard S, Doyle D, Pibarot P. Impact of valve prosthesis-patient mismatch on short-term mortality after aortic valve replacement. Circulation 2003; 108 (08) 983-988
• 19 Moon MR, Lawton JS, Moazami N, Munfakh NA, Pasque MK, Damiano Jr RJ. POINT: prosthesis-patient mismatch does not affect survival for patients greater than 70 years of age undergoing bioprosthetic aortic valve replacement. J Thorac Cardiovasc Surg 2009; 137 (02) 278-283
• 20 Chacko SJ, Ansari AH, McCarthy PM. , et al. Prosthesis-patient mismatch in bovine pericardial aortic valves: evaluation using 3 different modalities and associated medium-term outcomes. Circ Cardiovasc Imaging 2013; 6 (05) 776-783
• 21 Kunadian B, Vijayalakshmi K, Thornley AR. , et al. Meta-analysis of valve hemodynamics and left ventricular mass regression for stentless versus stented aortic valves. Ann Thorac Surg 2007; 84 (01) 73-78
• 22 Pibarot P, Dumesnil JG. Prosthetic heart valves: selection of the optimal prosthesis and long-term management. Circulation 2009; 119 (07) 1034-1048
• 23 Raghav V, Okafor I, Quach M, Dang L, Marquez S, Yoganathan AP. Long-term durability of Carpentier-Edwards Magna Ease Valve: a one billion cycle invitro study. Ann Thorac Surg 2016; 101 (05) 1759-1765
• 24 Nishioka N, Yamada A, Ujihira K. , et al. Outcomes of surgical aortic valve replacement using Carpentier-Edwards PERIMOUNT bioprosthesis series in elderly patients with severe aortic valve stenosis: a retrospective cohort study. Gen Thorac Cardiovasc Surg 2016; 64 (12) 728-734
• 25 You JH, Jeong DS, Sung K. , et al. Aortic valve replacement with Carpentier-Edwards: hemodynamic outcomes for the 19-mm valve. Ann Thorac Surg 2016; 101 (06) 2209-2216